VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS

K973517 · Johnson & Johnson Clinical Diagnostics, Inc. · JJY · Sep 25, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973517
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
• Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include TSH, Total T4. Total T3, T3 Uptake, LH, Progesterone, FSH, Total βhCG, Free T3 and Prolactin.

Device Story

VITROS Immunodiagnostic Products Range Verifiers are in vitro diagnostic reagents used to verify the calibration range of the VITROS Immunodiagnostic System. Used by laboratory professionals in clinical settings to ensure system accuracy across specified immunoassay ranges (TSH, T4, T3, T3 Uptake, LH, Progesterone, FSH, βhCG, Prolactin). The verifiers serve as a quality control tool to confirm that the instrument's measurement range is correctly calibrated, supporting clinical decision-making by ensuring reliable patient test results.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit for calibration verification. Designed for use with the VITROS Immunodiagnostic System. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for in vitro verification of calibration range for VITROS Immunodiagnostic System assays, including TSH, Total T4, Total T3, T3 Uptake, LH, Progesterone, FSH, Total βhCG, Free T3, and Prolactin.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is presented in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 5 397

Ann Quinn . Manager, Regulatory Affairs Johnson & Johnson Clinical Diagnostics, Inc. 100 Indiqo Creek Rochester , New York 14650

Re: K973517 VITROS Immunodiagnostic Products Range Verifiers Regulatory Class: I Product Code: JJY Dated: September 16, 1997 Received: September 17, 1997

Dear Ms. Quinn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ਼ੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Intended Use (Appendix C)

| Page | 1 of 1 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K973517 |
| Device Name: | VITROS Immunodiagnostic Products Range Verifiers |
| Indications for Use: | For <i>in vitro</i> use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include TSH, Total T4. Total T3, T3 Uptake, LH, Progesterone, FSH, Total βhCG, Free T3 and Prolactin. |

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | k923517 |

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use _ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109) (Optional Format 1-2-96)